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Home > "E" Clinical Trials Conditions > Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors  Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
For Condition: HIV Infection,Acquired Immunodeficiency Syndrome
Status: No longer recruiting
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: This study will evaluate the long-term (2- to 5-year) significance of anti-HIV antibodies in people who test positive for the antibodies but have no symptoms of HIV infection. The study will include people who had positive anti-HIV antibody blood tests by both the ELISA and Western Blot methods; those who had a positive ELISA test but negative Western Blot (false positive); and those who had a positive ELISA test and an indeterminate Western Blot. Participants will have a history and physical examination to assess risk factors for HIV infection and to look for signs and symptoms of HIV infection. In addition, they may have some or all of the following blood tests and procedures: 1) repeat ELISA; 2) repeat Western Blot and possibly other confirmatory tests; 3) attempt to isolate the HIV-1 virus from the blood by growing white blood cells in culture or to detect the virus by other methods; 4) polymerase chain reaction (PCR) to detect minute amounts of viral DNA; and 5) determination of immune defects associated with HIV infection. Participants will be followed at the NIH outpatient clinic every 6 months for 2 to 5 years depending on their test results. They will have a physical examination, fill out a questionnaire, and provide a blood sample for testing at each visit.
Details: The Human Immunodeficiency Virus (HIV-I) has been unequivocally established as the causative agent of the acquired immunodeficiency syndrome (AIDS) and the AIDS related complex (ARC). Antibody to this agent (anti-HIV) has been extensively evaluated and sensitive ELISA assays are commercially available as well as molecular assays for HIV RNA and DNA. Molecular and/or serologic markers for HIV are found in virtually all patients with AIDS and in a large proportion of individuals at high risk for AIDS including male homosexuals with multiple partners, intravenous drug abusers, hemophiliacs who received clotting factor concentrates prior to 1985, and female sexual partners of AIDS patients. This study was initiated in 1985 when it became apparent that blood transfusion represents a risk factor for HIV transmission. At that time, approximately 2% of patients who develop AIDS have no known risk factor except for the receipt of blood within 5 years of the onset of disease. As of the year 2000, there were 9047 reported cases of AIDS in the US attributed to blood, blood components or tissue. Extensive evaluation of the donors to these cases reveals a "high risk" donor in almost every case (high risk denotes inclusion in one of the established CDC high risk groups, the development of AIDS subsequent to donation, the presence of an abnormal T4/T8 ratio or the presence of anti-HIV). Routine screening of blood donors for anti-HIV was instituted in March 1985. At that time, 0.4% of donors were repeatedly reactive by EIA and 0.04% were true HIV carriers as evidenced by Western blot (WB). At present, the prevalence of repeat reaction is approximately 0.1 to 0.2% and the prevalence of true positives 0.01 to 0.02%. The current risk of transfusion transmitted HIV infection of transfusion transmitted HIV infection is estimated to be one transmission per 2 million donations. When this study was initiated in 1985, much less was know about HIV and its transmission modes an the study was designed to evaluate the anti-HIV positive donor and to assess: 1) the proportion of such donors who were truly infected with HIV; 2) the route of infection in the HIV+ donor; 3) the reason why donors with high-risk behavior continued to donate; 4) the immunologic consequences of HIV in a health donor population; 5) the clinical manifestations of HIV over time. Currently, the study is focusing only on the immunologic an clinical outcomes in the cohort that was initially enrolled.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Asymptomatic blood donors found to have reproducibly detectable anti-HIV antibody. These donors will come primarily from the Washington Red Cross, with a lesser number from the Department of Transfusion Medicine, NIH. The majority of study participants will be anti-HIV positive as confirmed by the WB specificity assay. Persons who are positive for anti-HIV by the screening ELISA assay, but who are not confirmed by WB. This control group will include those who are negative by WB and those who have indeterminate or atypical WB patterns. Persons who are HIV infected as a result of blood transfusion.
Total Enrollment: 325
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 850095; 85-CC-0095
Study Start Date: May 6, 1985
Record last reviewed: April 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004849
Other Acquired Immunodeficiency Syndrome Studies:
1. Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
2. Retrovirus Epidemiology Donor Study I (REDS I)
3. A Pilot/Dose-Finding Study of the Toxicity, Anti-Kaposi's Sarcoma (KS) Activity, and Immunologic Activity of Interleukin-12 Administered to Patients with AIDS-Associated KS
4. Continuing Care and Treatment for Patients with Cancer/AIDS/Skin Disease
5. Genetically Modified Lymphocytes to Treat HIV-infected Identical Twins - Study Modifications
Related Studies:
Other Acquired Immunodeficiency Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
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